On public health aspects of biotechnology and life sciences
A-10-2025-0274
Committee on Public Health · Rapporteur: Margarita de la Pisa Carrión
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Parliament's resolution on public health aspects of biotechnology and life sciences sets out its position ahead of the planned EU Biotech Act and European life sciences strategy.¶¶¶ It calls for a simplified, science-based regulatory framework for biotechnology in healthcare, a harmonised clinical trials system with approval timelines cut to 30 days, and clearer rules for ethics committees.¶¶ It asks for more public and private investment across the value chain, with the aim of reaching 3 % of GDP by 2030, and for support to start-ups, SMEs and university research.¶¶¶ It demands strong ethical oversight, protection of fundamental rights and data, and measures against misuse of genetic tests and gene editing.¶¶¶ It also calls for action on antimicrobial resistance, rare diseases, skills shortages and cross-border access to advanced therapies.¶¶¶
Committee position. The Committee on Public Health proposes a resolution calling for an EU Biotech Act that simplifies regulation, speeds up clinical trials, boosts investment and safeguards ethics and fundamental rights.¶¶¶
Key points
- Highlights that biotechnology therapies such as CAR-T, mRNA, CRISPR and other advanced therapy medicinal products are transforming care and prevention, and stresses the need for long-term strategic investment in biotechnological research.¶¶
- Emphasises the role of biotechnology in treating cancer, cardiovascular, rare, neurodegenerative, psychiatric, autoimmune, infectious and metabolic diseases, and in reducing animal testing through laboratory-grown tissues, stem cells and organ-on-a-chip.¶¶
- Calls for increased public investment in research and development for phage therapy and similar biotechnological solutions to antimicrobial resistance, and for public funding for rare and paediatric diseases.¶¶
- Calls for the EU Biotech Act to review, simplify and optimise the regulatory framework for biotechnology in healthcare while maintaining high safety, quality, efficacy and ethical standards, and to streamline procedures and improve patient access.¶
- Calls for a harmonised clinical trials framework with approval timelines reduced to 30 days through risk-based assessments, better coordination among regulators, and adapted pathways and fee structures for public-sector innovators.¶
- Calls on the Commission to explore a centralised coordination mechanism for clinical research governance, with the European Medicines Agency possibly coordinating, and stresses adequate resources for national authorities.¶
- Supports shared public-private ownership of publicly funded biotechnologies, fair pricing, and the use of regulatory and health technology assessment sandboxes under EMA oversight.¶¶
- Calls for targeted support for initiatives such as the European Virtual Human Twins, EU standards for validating digital tools, investment in biobanks and modelling databases, and a common EU framework for secure health data aligned with the European Health Data Space.¶
- Calls for structured EU support for biotechnology innovation districts, regional biotechnology innovation hubs, and stronger collaboration between universities, hospitals, patient organisations, start-ups, SMEs and industry.¶¶¶
- Calls for increased public and private investment in biotechnology, with the aim of reaching 3 % of GDP by 2030, and for dedicated instruments such as seed and venture capital and risk-sharing mechanisms.¶
- Calls on the Commission to explore an EU biotech innovation fund, to accelerate the unitary patent system, and to align the EU Biotech Act with the Pharma Package.¶
- Calls for strong ethical oversight, precautionary yet innovation-enabling regulation, cooperation among national ethics committees, and safeguards on genetic testing, gene editing and biomedical data.¶¶¶
Who is affected
- Patients in the EU, who should gain faster and more equal access to innovative therapies, including cross-border care.¶¶¶
- Biotechnology start-ups, scale-ups and SMEs, which would receive regulatory guidance, funding and intellectual property support.¶¶¶
- Universities and research centres, which are urged to transfer research into marketable solutions with public support.¶¶¶
- National regulators and ethics committees, which are asked to harmonise clinical trial approval and work with the European Medicines Agency.¶¶
- The Commission and Member States, which are asked to fund research, update rare disease plans and enforce cross-border healthcare rules.¶¶¶
Figures and deadlines
- Biotechnology patents accounted for approximately 5 % of all patent applications filed between 2001 and 2020.¶
- In 2020, the United States held 39 % of total biotech patents, the EU 18 % and China 10 %.
- Over 96 % of biotechnology patents are linked to industrial and medical applications.
- Rare diseases affect no more than 1 in 2 000 people, with between 6 000 and 8 000 different rare diseases affecting approximately 36 million people in the EU.¶
- Around 80 % of rare diseases have a genetic origin.
- In 2018, the biotechnology sector directly generated EUR 31 billion in GDP and over 210 000 direct jobs, supporting more than 625 000 additional jobs indirectly.¶
- Antimicrobial resistance is directly responsible for the death of more than 1 million people globally each year.¶
- Investment in biotechnology should be progressively increased, with the aim of reaching 3 % of GDP by 2030.¶
Legal basis: Articles 6, 8 and 21 of the Treaty on European Union; Articles 4, 5, 6, 9, 114, 151, 153, 168, 169, 173, 179 and 191 of the Treaty on the Functioning of the European Union.¶¶